MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2017-12-15 for SUR-FIT LOOP OSTOMY ROD 65MM 22355 manufactured by .
[95051750]
(b)(6). Based on the available information, this event is deemed to be a serious injury. Additional information has been requested, however to date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95051751]
It was reported by a representative at (b)(6) hospital that while performing surgery a piece of the loop ostomy rod dropped inside the patient during the operation due to a malfunction. According to the reporter, the product appeared intact when opening it. It was used to assist the surgeon on getting the loop of bowel out of the abdomen, which, according to the reporter, proved quite difficult. When they finally got the loop of the bowel out they realized? The moving (arrow shaped) part that spins around had come off from the rod. It had simply snapped off where the two pieces meet.? The reporter said the surgical team put the laparoscopic ports back in to re-inflate the abdomen to look where the piece had gone. According to the reporter,? It was found inside the abdomen, lying on top of the bowel.? They tried to get it out with different forceps but this proved unsuccessful. In the end they used a? Retrieval pouch (normally used for appendixes) to drop the rod inside and then retrieve the whole thing.? There was no injury to the patient or the stoma. The reporter said it was just very inconvenient and delayed things a bit. The reporter has no further information regarding the patient or current condition.
Patient Sequence No: 1, Text Type: D, B5
[113290436]
A review of the last three (3) product monitoring review? S for trends indicated no trends for this issue on this product. The historical complaint data from november 01, 2015 to november 30, 2017 was reviewed as it relates to reports for product part number 22355. A total of one (1) complaint, including this one, was reported. This issue will be monitored through the post market product monitoring review process. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2017-00090 |
| MDR Report Key | 7122643 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2017-12-15 |
| Date of Event | 2017-11-22 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2017-12-15 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT LOOP OSTOMY ROD 65MM |
| Generic Name | ROD, COLOSTOMY |
| Product Code | EZP |
| Date Received | 2017-12-15 |
| Model Number | 22355 |
| Lot Number | 3M00287 |
| Device Expiration Date | 2018-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-15 |