FDA Adverse Event
Other
Summary report: N
AUTO SUTURE PREMIUM MULTIFIRE TA 60-3.5
MDR report key: 295787
·
Received September 12, 2000
Report
- Report Number
- 295787
- Event Type
- Other
- Date Received
- September 12, 2000
- Date of Event
- May 15, 2000
- Report Date
- August 17, 2000
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT UNDERWENT A COLECTOMY IN 2000. THE BOWEL WAS REANASTOMOSED USING A PREMIUM MULTIFIRE TA 60-3.5 STAPLING DEVICE. REPORTEDLY, POST-OPERATIVELY, PT DEVELOPED ACUTE ABDOMINAL PAIN, TACHYCARDIA, AND FEVER. ABDOMINAL X-RAYS SHOWED THE PRESENCE OF FREE AIR IN THE PERITONEAL CAVITY. PT WAS RETURNED TO THE OR FOR AN EXPLORATORY LAPAROTOMY. AT THIS TIME, IT WAS NOTED THAT THERE WAS A 0.5CM DEHISCENCE OF THE STAPLE LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM MULTIFIRE TA 60-3.5 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |