MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for STERILE 3.5 ULTEM KOH-EFF AD750-KE35 manufactured by Coopersurgical, Inc..
[108734123]
(b)(4). Investigation: no sample returned. Review dhr. Analysis and findings: a review of the 2 year complaint history for the sterile 3. 5 ultem koh-eff shows some similar complaints on file. The complainant did not provide a lot number for the affected sample. A distribution report was generated for all sterile 3. 5 ultem koh-eff shipped to customer number 423415. A review of the dhr-ad750-ke35-207708, dhr-ad750-ke35-239039, dhr-ad750-ke35-239089, and dhr-ad750-ke35-241282 shows no nonconformities associated to this complaint. The reported condition could not be verified or confirmed due to the affected sample not being returned for investigative analysis. It should be noted that r&d engineering implemented a proactive product improvement to increase the effectiveness of the latch/lock (first production run 8/17). It should also be noted that past returned device samples prior to the corrective action that were returned for similar reported incidents were not reproducible. Evaluation tests were performed by r and d engineering on identical devices by placing thirty (30 lbs) pound weights atop the adapter drape when locked onto the tube, and could not replicate the reported events of the latch not holding; tests were performed in dry and wet states. A review of the risk management report and device pfmea (# 16 and 17) (advincula delineator (dsp)) were performed and both documents addressed the reported event with proper process controls or verification(s). This complaint is being closed in accordance with (b)(4). Should the affected samples be returned at a later date this complaint will be updated accordingly. Corrective actions: correction and/or corrective action: it should be noted that r and d engineering implemented a proactive product improvement to increase the effectiveness of the latch/lock (first production run 8/17). This complaint condition is considered a level 3 corrective action per (b)(4). Level 3 complaints will be continuously monitored for trends and addressed accordingly. Was the complaint confirmed? No.
Patient Sequence No: 1, Text Type: N, H10
[108734124]
Initial complaint: locking mechanism came undone during case. On 4/25/2018 follow up response received: 10. Please describe what was observed? The shaft of the delineator perforated the uterus. The locking mechanism failed from my observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00027 |
| MDR Report Key | 7512523 |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-14 |
| 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. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERILE 3.5 ULTEM KOH-EFF |
| Generic Name | STERILE 3.5 ULTEM KOH-EFF |
| Product Code | HEW |
| Date Received | 2018-05-14 |
| Model Number | AD750-KE35 |
| Catalog Number | AD750-KE35 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DR TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-14 |