MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN UNKNOWN KNIFELIGHT ENDOLUMINAL KNIFE INSTRUMENT

Catalog Number UNK_SEL

Device Problem Off-Label Use (1494)

Patient Problem Scarring (2061)

Event Date 09/01/2009

Event Type  Injury  

Manufacturer Narrative

Device will not be returned. If additional information becomes available it will be provided on a supplemental report.

Event Description

The manufacturer became aware of a study from ¿(b)(6)¿. The study was published on september 2009, within that publication, 8 cases involving knifelight endoluminal knife were reported, which were found to be off-label. The study states, ¿the only treatment is the fasciotomy of the compartments and the gold standard procedure is still the open-invasive surgery. The authors describe a new mini-invasive surgical procedure to perform a 4-compartment fasciotomy of the forearm and expose their results. ¿ it was not possible to ascertain specific catalog or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 8 complaints were initiated retrospectively for the off-label use mentioned in the report. This product inquiry addresses hypertrophic proximal volar scar.

• Brand Name: UNKNOWN UNKNOWN KNIFELIGHT ENDOLUMINAL KNIFE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER ENDOSCOPY-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8117500
• MDR Text Key: 128861074
• Report Number: 0008031020-2018-01011
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/29/2018 Patient Sequence Number: 1