PRECISION IDEAL EYES 5.5MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 30CM
Report
- Report Number
- 0002936485-2022-00759
- Event Type
- Malfunction
- Date Received
- December 15, 2022
- Date of Event
- December 1, 2022
- Report Date
- February 3, 2023
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327059144
- PMA / PMN Number
- K910132
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ALLEGED FAILURE: "KUNDE RAPPORTERER AT SCOPE ER SLØRET LÆGGER OPTIK TIL VI KAN KOMME FORBI OG TJEKKE. OPTIK SKØNNES VED SYN AT VÆRE SLØRET TRODS RENS MED POLISH PASTA OG GENEREL RENGØRING" "CUSTOMER REPORTS SCOPE IS BLURRY LAYING OPTICS UNTIL WE CAN COME BY AND CHECK. OPTICS ARE ESTIMATED TO BE BLURRY DESPITE CLEANING WITH POLISH PASTE AND GENERAL CLEANING" THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSES COULD BE ROUGH HANDLING DURING STERILIZATION AND/OR PRODUCT TRANSPORT. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2777913 | PRECISION IDEAL EYES 5.5MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 30CM | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE | 0502503030 | 07613327059144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |