MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-06 for PKG, SLIDING LOCK ATRAUMATIC GRASPER 0250080767 manufactured by Stryker Endoscopy-san Jose.
[101853565]
The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence. The top snapped, it did not remove completely, but was attached by a large portion. In order to remove it she had to remove the trocar and the instruments because the way it was snapped could not be cleanly removed. Does not believe there was any patient harm. The failure(s) identified in the investigation is consistent with the complaint record. The probable root causes could be excessive force, or rotational force with the jaw under load. The device manufacture date is not known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101853570]
It was reported that the top of the instrument snapped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00223 |
| MDR Report Key | 7319372 |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROOMI BANERJEE DUA |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PKG, SLIDING LOCK ATRAUMATIC GRASPER |
| Generic Name | FORCEPS, GENERAL & PLASTIC SURGERY |
| Product Code | GEN |
| Date Received | 2018-03-06 |
| Returned To Mfg | 2018-01-30 |
| Catalog Number | 0250080767 |
| Lot Number | 15401331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-06 |