BERCHTOLD CHROMOPHORE C-950G
Report
- Report Number
- MW1015465
- Event Type
- Injury
- Date Received
- January 19, 1999
- Date of Event
- January 14, 1999
- Report Date
- January 19, 1999
- Manufacturer
- BERCHTOLD CORP.
- Product Code
- FQP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
ON JANUARY 14, 1999, AN OPERATING ROOM WAS BEING USED TO PERFORM KNEE SURGERY. AT APPROX 9:15AM THE BERCHTOLD OPERATING ROOM LIGHT BROKE, SHOWERING A PT AND STAFF WITH GLASS. THE PT'S KNEE HAD BEEN OPENED DOWN TO THE JOINT CAPSULE PRIOR TO THE MALFUNCTION. THE STERILE FIELD WAS CONTAMINATED, NECESSITATING CANCELLATION OF THE OPERATION. A NEW STERILE FIELD WAS SET UP; THE WOUND WAS IRRIGATED TO REMOVE ANY POSSIBLE GLASS AND CLOSED. THE PT IS BEING MONITORED FOR ANY FURTHER ADVERSE OUTCOMES. ALL STAFF IN THE OPERATING ROOM AT THE TIME REPORTED TO PERSONNEL HEALTH FOR TREATMENT. GLASS WAS REMOVED FROM THE EYES OF THREE STAFF MEMBERS. ALL SUFFERED FROM CORNEAL ABRASION. THE MFR WAS IMMEDIATELY CONTACTED AND REQUESTED TO COME IN FOR AN INVESTIGATION. PT OPERATION TO BE RESCHEDULED IN THE FUTURE.
ON JANUARY 14, 1999, AN OPERATING ROOM WAS BEING USED TO PERFORM KNEE SURGERY. AT APPROX 9:15AM THE BERCHTOLD OPERATING ROOM LIGHT BROKE, SHOWERING A PT AND STAFF WITH GLASS. THE PT'S KNEE HAD BEEN OPENED DOWN TO THE JOINT CAPSULE PRIOR TO THE MALFUNCTION. THE STERILE FIELD WAS CONTAMINATED, NECESSITATING CANCELLATION OF THE OPERATION. A NEW STERILE FIELD WAS SET UP; THE WOUND WAS IRRIGATED TO REMOVE ANY POSSIBLE GLASS AND CLOSED. THE PT IS BEING MONITORED FOR ANY FURTHER ADVERSE OUTCOMES. ALL STAFF IN THE OPERATING ROOM AT THE TIME REPORTED TO PERSONNEL HEALTH FOR TREATMENT. GLASS WAS REMOVED FROM THE EYES OF THREE STAFF MEMBERS. ALL SUFFERED FROM CORNEAL ABRASION. THE MFR WAS IMMEDIATELY CONTACTED AND REQUESTED TO COME IN FOR AN INVESTIGATION. PT OPERATION TO BE RESCHEDULED IN THE FUTURE.
ON JANUARY 14, 1999, AN OPERATING ROOM WAS BEING USED TO PERFORM KNEE SURGERY. AT APPROX 9:15AM THE BERCHTOLD OPERATING ROOM LIGHT BROKE, SHOWERING A PT AND STAFF WITH GLASS. THE PT'S KNEE HAD BEEN OPENED DOWN TO THE JOINT CAPSULE PRIOR TO THE MALFUNCTION. THE STERILE FIELD WAS CONTAMINATED, NECESSITATING CANCELLATION OF THE OPERATION. A NEW STERILE FIELD WAS SET UP; THE WOUND WAS IRRIGATED TO REMOVE ANY POSSIBLE GLASS AND CLOSED. THE PT IS BEING MONITORED FOR ANY FURTHER ADVERSE OUTCOMES. ALL STAFF IN THE OPERATING ROOM AT THE TIME REPORTED TO PERSONNEL HEALTH FOR TREATMENT. GLASS WAS REMOVED FROM THE EYES OF THREE STAFF MEMBERS. ALL SUFFERED FROM CORNEAL ABRASION. THE MFR WAS IMMEDIATELY CONTACTED AND REQUESTED TO COME IN FOR AN INVESTIGATION. PT OPERATION TO BE RESCHEDULED IN THE FUTURE.
ON JANUARY 14, 1999, AN OPERATING ROOM WAS BEING USED TO PERFORM KNEE SURGERY. AT APPROX 9:15AM THE BERCHTOLD OPERATING ROOM LIGHT BROKE, SHOWERING A PT AND STAFF WITH GLASS. THE PT'S KNEE HAD BEEN OPENED DOWN TO THE JOINT CAPSULE PRIOR TO THE MALFUNCTION. THE STERILE FIELD WAS CONTAMINATED, NECESSITATING CANCELLATION OF THE OPERATION. A NEW STERILE FIELD WAS SET UP; THE WOUND WAS IRRIGATED TO REMOVE ANY POSSIBLE GLASS AND CLOSED. THE PT IS BEING MONITORED FOR ANY FURTHER ADVERSE OUTCOMES. ALL STAFF IN THE OPERATING ROOM AT THE TIME REPORTED TO PERSONNEL HEALTH FOR TREATMENT. GLASS WAS REMOVED FROM THE EYES OF THREE STAFF MEMBERS. ALL SUFFERED FROM CORNEAL ABRASION. THE MFR WAS IMMEDIATELY CONTACTED AND REQUESTED TO COME IN FOR AN INVESTIGATION. PT OPERATION TO BE RESCHEDULED IN THE FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BERCHTOLD CHROMOPHORE C-950G | OPERATING ROOM LIGHT | FQP | BERCHTOLD CORP. | C950G | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | ||
| 2 | UNKNOWN | Required Intervention | ||
| 3 | UNKNOWN | Required Intervention | ||
| 4 | UNKNOWN | Required Intervention |