FDA Adverse Event
Injury
Summary report: N
MTOME ST HOLSTER/CABLES
MDR report key: 1081613
·
Received July 25, 2008
Report
- Report Number
- 3005075853-2008-00682
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- KNW
- PMA / PMN Number
- K991980
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BREAST BIOPSY, AFTER REMOVING FOUR SAMPLES, THE REAR ROTATION KNOB TURNED ON ITS OWN, CUTTING INTO THE PT'S BREAST, CAUSING THE PT TO JUMP AND SCREAM IN PAIN. THE CUSTOMER WAS ABLE TO PLACE A CLIP, CLOSE THE SAMPLE CHAMBER AND REMOVED WITHOUT FURTHER INCIDENT. THE SKIN AROUND THE BREAST WAS SLIGHTLY TORN AND THERE WAS A SMALL AMOUNT OF BLOOD ON THE BUCKEY PLATE. THE PT WILL BE RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MTOME ST HOLSTER/CABLES | KNW | ETHICON ENDO-SURGERY, LLC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CONTROL MODULE |