MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-26 for OPERATING SCS 6-1/2 STR B/B 100138 manufactured by Integra York, Pa Inc..
[129354249]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report numbers: 2523190-2018-00145; 2523190-2018-00146; 2523190-2018-00147; 2523190-2018-00148; 2523190-2018-00149; 2523190-2018-00150; 2523190-2018-00151; 2523190-2018-00152; 2523190-2018-00153; 2523190-2018-00162; 2523190-2018-00154; 2523190-2018-00155; 2523190-2018-00156; 2523190-2018-00157; 2523190-2018-00163; 2523190-2018-00158; 2523190-2018-00159; 2523190-2018-00160; 2523190-2018-00161; 2523190-2018-00164; 2523190-2018-00166; 2523190-2018-00167.
Patient Sequence No: 1, Text Type: N, H10
[129354250]
This is 21 of 23 reports. It was reported by a customer that a 100138 ochsner operating scissor failed quality control with a suspected bioburden, causing an operating room delay on (b)(6) 2018, for an unspecified procedure. Additional information was received on 06-nov-2018, stating that the sterility of the device was compromised, it was tested for proteins and removed from the field. The surgical case was broken down. The device was not in contact with the patient. No reports of patient injury or death alleged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00165 |
| MDR Report Key | 8103490 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-11-26 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERATING SCS 6-1/2 STR B/B |
| Generic Name | N/A |
| Product Code | LRW |
| Date Received | 2018-11-26 |
| Returned To Mfg | 2018-11-13 |
| Catalog Number | 100138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-26 |