MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-03-17 for OLYMPUS A2637 83A2637 manufactured by Olympus Winter & Ibe Gmbh.
[123205]
During a bladder tumor resection procedure, the flexible tip of the a2637 obturator froze in an upward deflective position after being inserted into the pt. When the surgeon was unsuccessful in his attempts to remove the obturator from the inflow sheath, he exerted add'l pressure which caused the ceramic beak off the inflow sheath at the tip while the device was inside the pt. Although the surgeon attempted to retrieve the ceramic tip, the piece was not in view after the instrumentation had been removed. The surgeon is unsure whether the piece or multiple pieces will pass without assistance but add'l surgical intervention was not performed. A second complication developed as the surgeon attempted to withdraw the instrumentation. As he placed his hands on the obturator and the pt, and due to the amount of force being exerted, the surgeon inadvertently pushed the entire instrument assembly forward apparently causing perforation of the urethral wall. Eventually, the surgeon removed the instrument assembly and completed the original procedure with a second set of equipment. The perforation was not repaired since this type of perforation normally heals without intervention. However, the pt experienced bleeding as a result of the procedure and overnight hospitalization was required. Prior to the procedure, the pt was placed on antibiotics. Antibiotics were continued following this event. As of 2/26/98, the pt's condition was reportedly good. The pt is scheduled for a trans urethral resection procedure due to reasons potentially unrelated to this event.
Patient Sequence No: 1, Text Type: D, B5
[7778719]
Upon eval, the mfr found that the epoxy cement used to secure an internal screw in the deflecting tip of the obturator had deteriorated over time. This allowed the screw to shift, and as a result, the obturator locked in a deflected position. To counter this phenomenon, the mfr has validated a change to a laser welding process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-1998-00004 |
| MDR Report Key | 156628 |
| Report Source | 05 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-02-09 |
| Date of Event | 1998-02-09 |
| Date Mfgr Received | 1998-02-09 |
| Date Added to Maude | 1998-03-19 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-03-17 |
| Model Number | A2637 |
| Catalog Number | 83A2637 |
| Lot Number | 76W |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 152580 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 70 GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | A2637 |
| Baseline Catalog No | 83A2637 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K931995 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-03-17 |