MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CLIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.However, omsc launched only products that had passed the inspection.The malfunction of the subject device concerning this case has not been reported, and there is no information indicating the relationship between this reported event and the subject device.

Event Description

Olympus medical systems corp.(omsc) received a literature title "modified laparoscopic intragastric surgery and endoscopic full-thickness resection for gastric stromal tumor originating from the muscularis propria".The literature reported the results of a study based on modified laparoscopic intragastric surgery (mligs) or endoscopic full-thickness resection (efr) of 18 patients with gastric stromal tumors (gst) between january, 2011 and october, 2012.During the study period, efr was performed with the use of the subject device (olympus clip), and peritonitis and peritoneal abscess occurred in 1 patient.There is no description about the relationship between the subject device and adverse events, but the author states the following."1 patient in the efr group had peritonitis and peritoneal abscess, with a hospital stay of 36 days.Perhaps two reasons account for this: gastric fluid and blood escaping into peritoneal cavity during and after the operation and clips falling off before perforation healing.".

• Brand Name: CLIP
• Type of Device: CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10655462
• MDR Text Key: 215310611
• Report Number: 8010047-2020-07480
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K963160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR