MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for PKG, SLIDING LOCK ATRAUMATIC GRASPER 0250080767 manufactured by Stryker Endoscopy-san Jose.
[93418923]
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93418924]
It was reported while using the grasper during a surgery, a screw inside the grasper was thought to have come apart. The surgeon could not find the screw. There was a surgical delay of about 5-10 minutes. This is a conservative filing since the location of the missing piece is not confirmed.
Patient Sequence No: 1, Text Type: D, B5
[114213624]
(b)(4). The device manufacture date is not known. Alleged failure: while the grasper was in used, the jaw out inside the patient 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 product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[114213627]
It was reported while using the grasper during a surgery, a screw inside the grasper was thought to have come apart. The surgeon could not find the screw. There was a surgical delay of about 5-10 minutes. This is a conservative filing since the location of the missing piece is not confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2017-01160 |
| MDR Report Key | 7073011 |
| Date Received | 2017-11-30 |
| Date of Report | 2018-03-23 |
| Date of Event | 2017-10-29 |
| Date Mfgr Received | 2017-11-01 |
| Date Added to Maude | 2017-11-30 |
| 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. ASHLEY LOWER |
| 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 | 2017-11-30 |
| Returned To Mfg | 2017-11-20 |
| Catalog Number | 0250080767 |
| Lot Number | 1641718I |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2017-11-30 |