MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for PROTOSCOPES, SIGMOIDOSCOPES, ACC. 13901NKS manufactured by Karl Storz Endoscopy-america, Inc..
[59744086]
Patient Sequence No: 1, Text Type: N, H10
[59744087]
While removing the video sigmoidoscope from the light source, the sigmoidoscope body separated from the light source connection and the flexible endoscope sheath. This is the second occurrence of this type of failure on this sigmoidoscope model. Review with the user indicated that they did follow correct removal procedure. This scope was the exchange scope replacing a scope that had the same damage with separation of the light connector body and flexible sheath. Manufacturer response for video sigmoidoscope, (brand not provided) (per site reporter: manufacturer noted this was a warranty device delivered two months ago. Manufacturer called unit in. Biomedical engineering is requesting report on failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6098767 |
| MDR Report Key | 6098767 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-10 |
| Report Date | 2016-11-10 |
| Date Reported to FDA | 2016-11-10 |
| Date Reported to Mfgr | 2016-11-10 |
| Date Added to Maude | 2016-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | PROTOSCOPES, SIGMOIDOSCOPES, ACC. |
| Generic Name | SIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FAM |
| Date Received | 2016-11-14 |
| Returned To Mfg | 2016-11-10 |
| Model Number | 13901NKS |
| Catalog Number | 13901NKS |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 40 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVE. EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |